Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery

NCT03488147 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: GCO 12-1433
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.

Conditions

Dysphagia; GERD; Degenerative Joint Disease

Keywords

Esomeprazole Magnesium; Postoperative dysphagia; Gastroesophageal reflux disease; Anterior cervical surgery; Proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Dysphagia questionnaire

  The Dysphagia questionnaire is a 2 item questionnaire with full scale from 0 (no swallowing difficulty) to 10 (frequent swallowing difficulty)

  12 weeks post surgery

Study Arms (3)

Esomeprazole Only

EXPERIMENTAL

Subjects assigned to the treatment group 'A' will receive one 20 mg esomeprazole tablet daily starting 1 week prior to the cervical operation and will continue to receive the esomeprazole until the end of the study

Drug: Esomeprazole

Esomeprazole and Placebo Oral Tablet

ACTIVE COMPARATOR

Subjects belonging to the treatment group 'B' will receive one placebo tablet (physically resembling an esomeprazole tablet 20 mg ) daily starting one week prior to the cervical operation. Subjects will then receive one 20 mg esomeprazole daily starting immediately after the operation and will continue to receive the esomeprazole until the end of the study.

Drug: Esomeprazole; Drug: Placebo Oral Tablet

Placebo Oral Tablet Only

PLACEBO COMPARATOR

Subjects belonging to the treatment group 'C' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation and will continue to receive the placebo tablet until the end of the study

Drug: Placebo Oral Tablet

Interventions

Esomeprazole DRUG

20 mg esomeprazole tablet

Esomeprazole Only; Esomeprazole and Placebo Oral Tablet

Placebo Oral Tablet DRUG

resembling esomeprazole tablet

Esomeprazole and Placebo Oral Tablet; Placebo Oral Tablet Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age.
• Scheduled to undergo anterior cervical surgery for degenerative joint disease.

You may not qualify if:

• Patients undergoing revision procedures, multi-level procedures, or procedures treating conditions other than degenerative joint disease.
• Patients with preoperative dysphagia.
• Patients currently taking any acid suppressing medications (proton pump inhibitors, H2 blockers, antacids, etc).
• Patients who are pregnant or nursing.
• Patients who, due to drug allergies, hypersensitivities/anaphylactic reactions to esomeprazole or contraindications (hypersensitivity to benzimidazoles, osteoporosis), are unable to take esomeprazole.
• Patients unable to attend follow-up visits or answer the dysphagia questionnaires.
• Eligibility Criteria:
• Scheduled to undergo anterior cervical surgery for degenerative joint disease.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai West

New York, New York, 10019, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Gastroesophageal Reflux; Joint Diseases

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrew C Hecht, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects assigned to the treatment group 'A' will receive one 20 mg esomeprazole tablet daily starting 1 week prior to the cervical operation and will continue to receive the esomeprazole until the end of the study (12 week follow-up). Subjects belonging to the treatment group 'B' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation. Subjects will then receive one 20 mg esomeprazole daily starting immediately after the operation and will continue to receive the esomeprazole until the end of the study. Subjects belonging to the treatment group 'C' will receive one placebo tablet (physically resembling a 20 mg esomeprazole tablet) daily starting one week prior to the cervical operation and will continue to receive the placebo tablet until the end of the study (12 week follow-up).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Chief, Spine Surgery, Director, Mount Sinai Spine Center

Model Details: After consent has been obtained, eligible subjects will be randomized into 1 of 3 different treatment groups designated A, B, and C, using a random number generator.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 4, 2018
• Study Start: July 1, 2020
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

US (2)